scholarly journals The continued use of placebo arms in COVID-19 vaccine trials does not adequately protect the well-being of participants

2021 ◽  
pp. 01-06
Author(s):  
Bridget Haire
Keyword(s):  
Well Being ◽  
High Quality ◽  
International Ethics ◽  
Vaccine Trials ◽  
Placebo Controls ◽  
Effective Interventions ◽  
Guidance Documents ◽  
Continued Use ◽  
Study Designs ◽  
Optimal Implementation

Covid-19 vaccines are a critical tool for controlling the pandemic. While safe and effective vaccines have been developed, research is expected to continue for many years regarding the optimal implementation of existing vaccines in specific settings, and the development of second-generation vaccines that may offer advantages in terms of either efficacy or ease of implementation. Given this context, some commentators have argued that new Covid vaccine trials should be able to use placebo controls, and that existing studies should be able to continue with blinded participants in order to collect high quality, unbiased data. Using international ethics guidance documents, this paper argues against placebo controls, given the existence of proven effective interventions, and against protracted blinding once safety and efficacy milestones have been met. Instead, it advocates for study designs that allow for direct comparison between approved and experimental vaccines, which facilitates both data collection and greater access to vaccines.

Assessment

2019 ◽  
Author(s):  
Robin Detterman ◽  
Jenny Ventura ◽  
Lihi Rosenthal ◽  
Ken Berrick
Keyword(s):  
General Education ◽  
Planning Process ◽  
Well Being ◽  
Logic Model ◽  
High Quality ◽  
Climate Assessment ◽  
School Year ◽  
Effective Interventions ◽  
Culture And Climate

By now it should be apparent that unconditional education (UE) is both comprehensive in its scope and ambitious in its goals. This chapter will help outline the formative assessment process that has been created as a means to inform high-quality program planning and implementation and summative assessments used to measure the extent to which the model promotes positive outcomes for students and schools. The two overarching goals of implementing this model are (1) to increase the academic performance and social-emotional well-being of the most struggling students and (2) to increase the capacity of schools serving highly stressed communities to deliver effective interventions through the implementation of a transdisciplinary multi-tiered framework. The second goal relates to capacity building and systems change within the school community itself; while the first relates to the outcomes these changes bring about. More information about the model’s overall theory of action can be found in the logic model in Appendix 7.1. The logic model also highlights the four key components of UE and the implementation strategies related to them. These key components are as follows: …System efficiency, resources match the level of identified student need and schools are able to leverage braided funding, including general education, special education, and mental health dollars. Coordination of services, a transdisciplinary team reviews data, assigns students to intervention, and monitors their progress. Universal supports/Tier 1, a culture and climate team engages in a schoolwide assessment and planning process explained in great detail later in this chapter. Targeted and intensive supports, data-informed, high-quality interventions are implemented with fidelity and monitored for effectiveness…. The strategies related to these four key components are expected to influence a set of comprehensive, long-term outcomes. These outcomes measure the extent to which the model has improved school culture and climate (as measured by the School Climate Assessment Instrument), increased academic achievement (as measure by standardized tests), improved behavior outcomes (as measured by suspension rates), and increased attendance. While data are reviewed at the end of every school year, it is not until the third year that a substantial impact on these long-term measures is expected.

scholarly journals Following the Science to Generate Well-Being: Using the Highest-Quality Experimental Evidence to Design Interventions

2021 ◽  
Vol 12 ◽  
Author(s):  
Stewart I. Donaldson ◽  
Victoria Cabrera ◽  
Jaclyn Gaffaney
Keyword(s):  
Well Being ◽  
Equitable Access ◽  
High Quality ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Effective Interventions ◽  
Global Pandemic ◽  
Rigorous Research ◽  
Meta Analyses ◽  
Second Wave

The second wave of devastating consequences of the COVID-19 pandemic has been linked to dramatic declines in well-being. While much of the well-being literature is based on descriptive and correlational studies, this paper evaluates a growing body of causal evidence from high-quality randomized controlled trials (RCTs) that test the efficacy of positive psychology interventions (PPIs). This systematic review analyzed the findings from 25 meta-analyses, 42 review papers, and the high-quality RCTs of PPIs designed to generate well-being that were included within those studies. Findings reveal PPIs have the potential to generate well-being even during a global pandemic, with larger effect sizes in non-Western countries. Four exemplar PPIs—that have been tested with a high-quality RCT, have positive effects on well-being, and could be implemented during a global pandemic—are presented and discussed. Future efforts to generate well-being can build on this causal evidence and emulate the most efficacious PPIs to be as effective as possible at generating well-being. However, the four exemplars were only tested in WEIRD (Western, Educated, Industrial, Rich, and Democratic) countries but seem promising for implementation and evaluation in non-WEIRD contexts. This review highlights the overall need for more rigorous research on PPIs with more diverse populations and in non-WEIRD contexts to ensure equitable access to effective interventions that generate well-being for all.

Compensatory Coping Through the Extension of Working Hours

2019 ◽  
Vol 63 (3) ◽  
pp. 115-128 ◽  
Author(s):  
Maie Stein ◽  
Sylvie Vincent-Höper ◽  
Nicole Deci ◽  
Sabine Gregersen ◽  
Albert Nienhaus
Keyword(s):  
Job Demands ◽  
Working Hours ◽  
Well Being ◽  
Leader Member Exchange ◽  
Workplace Health ◽  
High Quality ◽  
Data Analyses ◽  
Member Exchange ◽  
The Relationship ◽  
Advance Knowledge

Abstract. To advance knowledge of the mechanisms underlying the relationship between leadership and employees’ well-being, this study examines leaders’ effects on their employees’ compensatory coping efforts. Using an extension of the job demands–resources model, we propose that high-quality leader–member exchange (LMX) allows employees to cope with high job demands without increasing their effort expenditure through the extension of working hours. Data analyses ( N = 356) revealed that LMX buffers the effect of quantitative demands on the extension of working hours such that the indirect effect of quantitative demands on emotional exhaustion is only significant at low and average levels of LMX. This study indicates that integrating leadership with employees’ coping efforts into a unifying model contributes to understanding how leadership is related to employees’ well-being. The notion that leaders can affect their employees’ use of compensatory coping efforts that detract from well-being offers promising approaches to the promotion of workplace health.

scholarly journals Determining the psychometric properties of a novel questionnaire to measure “preparedness for the future” (Prep FQ)

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Daren K. Heyland ◽  
J. Paige Pope ◽  
Xuran Jiang ◽  
Andrew G. Day
Keyword(s):  
Quality Of Life ◽  
Construct Validity ◽  
Health Behaviors ◽  
Psychometric Properties ◽  
Well Being ◽  
High Quality ◽  
The Future ◽  
Quality Of Death ◽  
Test Retest Reliability

Abstract Background People are living longer than ever before. However, with living longer comes increased problems that negatively impact on quality of life and the quality of death. Tools are needed to help individuals assess whether they are practicing the best attitudes and behaviors that are associated with a future long life, high quality of life, high quality of death and a satisfying post-death legacy. The purpose of paper is to describe the process we used to develop a novel questionnaire (“Preparedness for the Future Questionnaire™ or Prep FQ”) and to define its psychometric properties. Methods Using a multi-step development procedure, items were generated, for the new questionnaire after which the psychometric properties were tested with a heterogeneous sample of 502 Canadians. Using an online polling panel, respondents were asked to complete demographic questions as well as the Prep-FQ, Global Rating of Life Satisfaction, the Keyes Psychological Well-Being scale and the Short-Form 12. Results The final version of the questionnaire contains 34 items in 8 distinct domains (“Medico-legal”, “Social”, “Psychological Well-being”, “Planning”, “Enrichment”, “Positive Health Behaviors”, “Negative Health Behaviors”, and “Late-life Planning”). We observed minimum missing data and good usage of all response options. The average overall Prep FQ score is 51.2 (SD = 13.3). The Cronbach alphas assessing internal reliability for the Prep FQ domains ranged from 0.33 to 0.88. The intra-class correlation coefficient (ICC) used to assess the test–retest reliability had an overall score of 0.87. For the purposes of establishing construct validity, all the pre-specified relationships between Prep FQ and the other questionnaires were met. Conclusion Analyses of this novel measure offered support for its face validity, construct validity, test–retest reliability, and internal consistency. With the development of this useful and valid scale, future research can utilize this measure to engage people in the process of comprehensively assessing and improving their state of preparedness for the future, tracking their progress along the way. Ultimately, this program of research aims to improve the quality and quantity of peoples live by helping them ‘think ahead’ and ‘plan ahead’ on the aspects of their daily life that matter to their future.

scholarly journals Across the COVID-19 Waves; Assessing Temporal Fluctuations in Perceived Stress, Post-Traumatic Symptoms, Worry, Anxiety and Civic Moral Disengagement over One Year of Pandemic

2021 ◽  
Vol 18 (11) ◽  
pp. 5651
Author(s):  
Alessio Gori ◽  
Eleonora Topino
Keyword(s):  
Perceived Stress ◽  
State Anxiety ◽  
Moral Disengagement ◽  
Online Survey ◽  
Well Being ◽  
First Year ◽  
Effective Interventions ◽  
Post Traumatic ◽  
One Year ◽  
Traumatic Symptoms

This study aimed at investigating the psychological effect of the COVID-19 pandemic in Italy by analysing the trends of perceived stress, post-traumatic symptoms, state anxiety, worry, and civic moral disengagement in four different moments from March 2020 to March 2021. The study involved a total of 1827 Italian participants (30% men and 70% women; Mage = 34.72; SD = 12.40) divided into four groups to which an online survey was administered. The first group completed the survey in March 2020, the second one in August 2020, the third one in November 2020, and the fourth one in March 2021. Results highlighted significant decreases in post-traumatic symptoms and a significant increase in civic moral disengagement over the first year of the COVID-19 pandemic. The levels of perceived stress, worry, and state anxiety remained constant. The correlations between the variables at different times were also explored, as well as gender differences over the year. The COVID-19 emergency has had significant effects on the mental state of the population, with important repercussions for individual and collective well-being during but probably also after the pandemic. This study offers a clear snapshot of the psychological outcomes over one COVID-19 pandemic year, providing important information that may contribute to tailor more effective interventions for mental health.

Selected Aspects of Ocular Toxicity Studies With a Focus on High-Quality Pathology Reports: A Pathology/Toxicology Consultant’s Perspective

2020 ◽  
pp. 019262332094671
Author(s):  
Brian Short
Keyword(s):  
Species Selection ◽  
Toxicity Study ◽  
Pathology Report ◽  
Ocular Toxicity ◽  
High Quality ◽  
Contract Research Organization ◽  
Toxicity Studies ◽  
Fit For Purpose ◽  
Pathology Reports ◽  
Study Designs

Ocular toxicity studies are the bedrock of nonclinical ocular drug and drug–device development, and there has been an evolution in experience, technologies, and challenges to address that ensures safe clinical trials and marketing authorization. The expectations of a well-designed ocular toxicity study and the generation of a coherent, integrative ocular toxicology report and subreports are high, and this article provides a pathology/toxicology consultant’s perspective on achieving that goal. The first objective is to cover selected aspects of study designs for ocular toxicity studies including considerations for contract research organization selection, minipig species selection, unilateral versus bilateral dosing, and in-life parameters based on fit-for-purpose study objectives. The main objective is a focus on a high-quality ocular pathology report that includes ocular histology procedures to meet regulatory expectations and a report narrative and tables that correlate microscopic findings with key ophthalmic findings and presents a clear interpretation of test article-, vehicle-, and procedure-related ocular and extraocular findings with identification of adversity and a pathology peer review. The last objective covers considerations for a high-quality ophthalmology report, which in concert with a high-quality pathology report, will pave the way for a best quality toxicology report for an ocular toxicity study.

scholarly journals Coping Behavior of Persons with Disabilities as a Factor of Quality of Life and Subjective Well-Being

2018 ◽  
Vol 26 (4) ◽  
pp. 101-118 ◽  
Author(s):  
S.A. Khazova ◽  
N. Shipova ◽  
T.N. Adeeva ◽  
I.V. Tikhonova
Keyword(s):  
Quality Of Life ◽  
Coping Strategies ◽  
Coping Behavior ◽  
Well Being ◽  
Separate Analysis ◽  
Subjective Well Being ◽  
High Quality ◽  
Persons With Disabilities ◽  
Rehabilitation Programs

The article presents an analysis of the problem of determining disabled-since-childhood adults’ quality of life. We suggested that coping behavior was a factor of high quality of life and subjective well-being. The sample (N=102) included disabled-since-childhood adults’ (N=51) with visual (N=16), hearing (N=18) and mobility disabilities (N=17) and adults with typical development (N=51). The respondents` average age is 37 years. Methods: the brief questionnaire WHOQOL-BREF in the adaptation of the V.M. Bechterev Research Institute; M.V. Sokolova’s Subjective Well-Being Scale; The Ways of Coping Questionnaire (Folkman, Lazarus, adapted by Kryukova T.L., Kuftyak E.V.). The results indicate a sufficiently high quality of life of adults with disabilities regardless of the type of disorders. The links between coping strategies, indicators of quality of life and subjective well-being are described. Distancing, avoidance and positive revaluation strategies make the greatest contribution to the quality of life. We conducted a separate analysis of the determination of the quality of life by coping strategies in groups of people with various disabilities. The results of the study can be used to develop rehabilitation programs and help people with disabilities.

POTENTIAL ALTERNATIVES TO LAMB MILK REPLACER FOR THE ARTIFICIAL REARING OF LAMBS

1982 ◽  
Vol 62 (4) ◽  
pp. 1135-1142 ◽  
Author(s):  
D. P. HEANEY ◽  
J. N. B. SHRESTHA ◽  
H. F. PETERS
Keyword(s):  
Key Words ◽  
Well Being ◽  
Cow Milk ◽  
Milk Replacer ◽  
Artificial Rearing ◽  
High Quality ◽  
Milk Products ◽  
Feed Costs ◽  
Spray Dried ◽  
General Appearance

Two experiments were conducted to evaluate the relative performance of artificially reared lambs fed four types of liquid diets: (1) lamb milk replacer (LMR) with 24% protein from spray-dried milk products and 24% fat in the dry powder; (2) high quality calf milk replacer (CMR) with 20% protein from spray-dried milk products and 20% fat; (3) fresh cow milk (CM); or (4) equal proportions of LMR and CM (LMR:CM). Average daily gains of lambs fed CMR or CM were lower by 16% and 12%, respectively, and weaning weights were lower by 10% and 5%, respectively, than those of lambs fed LMR. Gains and weaning weights of lambs fed LMR:CM were identical to those fed LMR. Lamb survival was marginally lower among CMR- and CM-fed lambs compared with those fed LMR. There were no observable differences among any of the feeding regimens in the general appearance, thriftiness or well-being of the lambs. The results indicate that, with good management, satisfactory lamb performance under artificial rearing can be achieved with high quality CMR or CM and that under practical conditions lower feed costs could offset the marginal reduction in lamb performance. Key words: Lambs, artificial rearing

Why We Ought to Accept the Repugnant Conclusion

Utilitas ◽  
2002 ◽  
Vol 14 (3) ◽  
pp. 339-359 ◽  
Author(s):  
Torbjorn Tannsjo
Keyword(s):  
Quality Of Life ◽  
Well Being ◽  
Derek Parfit ◽  
Worth Living ◽  
Repugnant Conclusion ◽  
High Quality ◽  
Hedonistic Utilitarianism ◽  
Sentient Beings ◽  
Very High

Derek Parfit has famously pointed out that ‘total’ utilitarian views, such as classical hedonistic utilitarianism, lead to the conclusion that, to each population of quite happy persons there corresponds a more extensive population with people living lives just worth living, which is (on the whole) better. In particular, for any possible population of at least ten billion people, all with a very high quality of life, there must be some much larger imaginable population whose existence, if other things are equal, would be better, even though its members have lives that are barely worth living. This world is better if the sum total of well-being is great enough, and it is great enough if only enough sentient beings inhabit it. This conclusion has been considered by Parfit and others to be ‘repugnant’.

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